A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas
- Determine the maximum tolerated dose of UCN-01 in combination with prednisone in
patients with refractory solid tumors or lymphomas.
- Determine the toxic effects of this regimen in these patients.
- Assess the pharmacokinetics of this regimen in these patients.
- Assess any tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of UCN-01.
Patients receive oral prednisone daily on days 1-5 and UCN-01 IV over 36-72 hours on days
3-5. Courses repeat every 28 days for up to 2 years in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the
recommended phase II dose.
Patients are followed every 3-12 months for 5 years.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 18
Primary Purpose: Treatment
Giovanni Melillo, MD
National Cancer Institute - Frederick
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|
|Frederick Cancer Research and Development Center||Frederick, Maryland 21702-1201|